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Key risk areas

As well as considering the research proposal and the answers to the questions on the application form (and checking them against the criteria on the checklist) the co-ordinator and/or research approval group should also consider the following issues.

The vulnerability of the research participants

Some prospective participants including children, people with learning difficulties or service users with mental health issues may not be able to give informed consent. Before commencing any research it is essential that consent is obtained from a responsible person with the legal ability to give such consent on the subject’s behalf.

The researcher’s experience

The level of experience of the researcher is likely to have a bearing on the way in which research is carried out and the impact on the participants. This may range from general inexperience, e.g. being a student, to lacking any real knowledge of the subject matter, to lack of experience of working with the client group through to lack of knowledge of the best methods to use in the research. It is essential to ascertain the level to which the researcher’s qualifications and experience are relevant and appropriate to the research area and methodology.

Research method and any additional issues this may raise

For example, research requiring participants to be interviewed in their own homes means increased levels of disclosure of personal information and potential risk.

Collection of sensitive information

Before approval is given for research involving the collection of sensitive information, such as criminal records, psychiatric history or health status, special consideration must be given to whether the collection of this information is justified and if it is justifiable, to what extent the research is in the interests of the research subject?

Privacy and confidentiality

Are the proposed methods of ensuring anonymity and confidentiality of participants adequate? Does the information collection process conform to the Data Protection Act 1998 and local Caldicott Guardian standards?

Requirement for consent

All research requires an information sheet to be provided to participants and a consent form to be completed before any interviews can be carried out. It is important the research proposal defines the potential benefits of the research, along with how the necessary consent will be obtained.

Reluctant participants may still be willing to take part if they feel the study has a wider benefit
If informed consent cannot be obtained, however, the participant cannot be interviewed as part of the research.

Sensitivity of research

The actual subject matter for a proposed research project should be considered carefully along with the professional experience and background of the researcher. For example, research into bereavement or sexuality is likely to require a greater level of expertise and professional knowledge than research into satisfaction around meals on wheels.

Where the proposed topic is sensitive, at the point of informed consent participants should also be asked if they are prepared to accept the possibility that distress may be caused and should be reminded that they can choose not to take part in the study at any stage. Any information given up to this stage should be destroyed.

Potential need for planned follow-up support where necessary

Where particularly sensitive areas are to be researched, the need and capacity for follow up by both the researcher and the social services department should be taken into account as this may have resource implications, as well as personal consequences, particularly for research participants.

External considerations

Research may generate interest by the media, public concern, political agendas and implications arising from the findings. Is there the possibility that the findings will be misinterpreted or misrepresented? Do the research timescales mean there is a danger that a lack of time could lead to incomplete or inaccurate findings? Hence the need to ensure that the timetable is realistic. If the findings are unpalatable to certain stakeholders or liable to be exaggerated to suit an agenda, how will that be dealt with?

Risk assessment

Will the research involve only minimal and predictable risk to the participants and/or the researcher and are the levels of risk acceptable? Are there any health and safety issues and if so, is a risk assessment necessary? Examples of when there may be health and safety issues could include research where interviews are conducted by a single researcher in isolation or when interviews are planned to take place in participants’ homes in the evenings.